Drug Approvals for November 1996

Definitions and Notes

November 1996

Original New Drug Applications

Original Application #: 020397
Approval Date: 27-NOV-96
Trade Name: ZANAFLEX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ATHENA NEUROSCIENCES INC
Active Ingredient(s): TIZANIDINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the acute and intermittent management of increased muscle tone associated with spasticity

Original Application #: 020690
Approval Date: 25-NOV-96
Trade Name: ARICEPT
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: EISAI AMERICA INC
Active Ingredient(s): DONEPEZIL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of mild to moderate dementia of the Alzheimer's Type

Original Application #: 050742
Approval Date: 22-NOV-96
Trade Name: STROMECTOL
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): IVERMECTIN
OTC/RX Status: RX
Indication(s): Treatment of strongyloidiasis and onchocerciasis

Original Application #: 050729
Approval Date: 22-NOV-96
Trade Name: AMPHOTEC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: SEQUUS PHARMACEUTICALS INC
Active Ingredient(s): AMPHOTERICIN B CHOLESTERYL SULFATE COMPLEX
OTC/RX Status: RX
Indication(s): Treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate in effective doses, and in patients with invasive aspergillosis where prior amphotericin B deoxycholate therapy has failed

Original Application #: 020700
Approval Date: 19-NOV-96
Trade Name: MUSE
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: SUPPOSITORY
Applicant: VIVUS INC
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX
Indication(s): Treatment of erectile dysfunction

Original Application #: 020601
Approval Date: 15-NOV-96
Trade Name: CHILDREN'S MOTRIN
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Indication(s): Temporary relief of minor aches and pains and the reduction of fever in children ages 4 to 11

Original Application #: 019722
Approval Date: 05-NOV-96
Trade Name: NASCOBAL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: NASTECH PHARMACEUTICAL CO INC
Active Ingredient(s): CYANOCOBALAMIN
OTC/RX Status: RX
Indication(s): Maintenance of the hematologic status of patients who are in remission following intramuscular vitamin B12 therapy

Original Application #: 020544
Approval Date: 01-NOV-96
Trade Name: LEVONORGESTREL IMPLANTS
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: IMPLANT
Applicant: POPULATION COUNCIL
Active Ingredient(s): LEVONORGESTREL
OTC/RX Status: RX
Indication(s): Prevention of pregnancy

Original Application #: 020114
Approval Date: 01-NOV-96
Trade Name: ASTELIN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SPRAY, METERED
Applicant: WALLACE LABORATORIES DIV CARTER WALLACE INC
Active Ingredient(s): AZELASTINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 12 years and older

Efficacy Supplemental New Drug Applications

Application #: 020460Efficacy Supplement#:006
Type: SE1 to Original New Drug Application
Approval Date: 27-NOV-96
Trade Name: CYTOVENE
Dosage Form: CAPSULE
Applicant: ROCHE GLOBAL DEVELOPMENT
Active Ingredient(s): GANCICLOVIR
OTC/RX Status: RX
Efficacy Claim: Prevention of CMV disease in solid organ transplant recipients

Application #:019810EfficacySupplement #:036
Type: SE1 to Original New Drug Application
Approval Date: 26-NOV-96
Trade Name: PRILOSEC
Dosage Form: CAPSULE, DELAYED RELEASE GRANULES
Applicant: ASTRA MERCK INC
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX
Efficacy Claim:Treatment of symptomatic gastroesophageal reflux disease (GERD)

Application #:050670Efficacy Supplement#:008
Type: SE1 to Original New Drug Application
Approval Date: 22-NOV-96
Trade Name: ZITHROMAX
Dosage Form: CAPSULE
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX
Efficacy Claim: Treatment of urethritis and cervicitis due to Nersseria gonorrhoeae and treatment of Chancroid in males due to Haemophilus ducreyi

Application #: 018936EfficacySupplement#:004
Type: SE1 to Original New Drug Application
Approval Date: 21-NOV-96
Trade Name: PROZAC
Dosage Form: CAPSULE
Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim:Treatment of Bulimia

Application #:050668 Efficacy Supplement#:013
Type: SE5 to Original New Drug Application
Approval Date: 13-NOV-96
Trade Name: LORABID
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): LORACARBEF
OTC/RX Status: RX
Efficacy Claim:Patient Population Altered-for use in acute maxillary sinusitis in children 6 months to 12 years of age

Application #: 050667Efficacy Supplement#:011
Type: SE5 to Original New Drug Application
Approval Date: 13-NOV-96
Trade Name: LORABID
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): LORACARBEF
OTC/RX Status: RX
Efficacy Claim:Claim:Patient Population Altered-for use in acute maxillary sinusitis in children 6 months to 12 years of age

Application #: 019297 Efficacy Supplement #: 014
Type: SE1 to Original New Drug Application
Approval Date: 13-NOV-96
Trade Name: NOVANTRONE
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): MITOXANTRONE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Use in combination with corticosteroids as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer.

Application #: 050580; Efficacy Supplement #: 008
Type: SE1 to Original New Drug Application
Approval Date: 01-NOV-96
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: ER SQUIBB AND SONS INC
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX
Efficacy Claim: Expanded use of Azactam in pediatric patients

Application #: 019918; Efficacy Supplement #: 004
Type: SE1 to Original New Drug Application
Approval Date: 01-NOV-96
Trade Name: NIX
Dosage Form: LOTION
Applicant: WARNER LAMBERT
Active Ingredient(s): PERMETHRIN
OTC/RX Status: OTC
Efficacy Claim: Prophylactic use during head lice epidemics

Approvable Original New Drug Applications

Original Application #: 020292
Approvable Date: 15-NOV-96
Trade Name: FERRISELTZ
Dosage Form: POWDER, FOR ORAL SOLUTION
Applicant: ONCOMEMBRANE INC
Active Ingredient(s): FERRIC AMMONIUM CITRATE BROWN
OTC/RX Status: RX

Original Application #: 050731
Approvable Date: 14-NOV-96
Trade Name: DAUNORUBICIN HCL
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): DAUNORUBICIN HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020227
Approvable Date: 13-NOV-96
Trade Name: NORMIFLO
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ARDEPARIN SODIUM
OTC/RX Status: RX

Original Application #: 020649
Approvable Date: 08-NOV-96
Trade Name: EDEX
Dosage Form: INJECTABLE
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX

Original Application #: 020632
Approvable Date: 08-NOV-96
Trade Name: MERIDIA
Dosage Form: CAPSULE
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE
OTC/RX Status: RX

Original Application #: 020668
Approvable Date: 06-NOV-96
Trade Name: LEXXEL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ASTRA MERCK INC
Active Ingredient(s): ENALAPRIL MALEATE; FELODIPINE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074817
Approval Date: 27-NOV-96
Trade Name: INVAGESIC
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): CAFFEINE; ASPIRIN; ORPHENADRINE CITRATE
OTC/RX Status: RX

Original Abbreviated Application # 074600
Approval Date: 27-NOV-96
Trade Name: CLOMIPRAMINE HCL
Dosage Form: CAPSULE
Applicant: CIRCA PHARMACEUTICALS INC
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040135
Approval Date: 27-NOV-96
Trade Name: ESTROPIPATE
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): ESTROPIPATE
OTC/RX Status: RX

Original Abbreviated Application # 074700
Approval Date: 21-NOV-96
Trade Name: BUMETANIDE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): BUMETANIDE
OTC/RX Status: RX

Original Abbreviated Application # 040134
Approval Date: 21-NOV-96
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: UCB PHARMA INC
Active Ingredient(s): HYDROCODONE BITARTRATE; ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 074602
Approval Date: 14-NOV-96
Trade Name: LACTULOSE
Dosage Form: SOLUTION
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): LACTULOSE
OTC/RX Status: RX

Original Abbreviated Application # 074629
Approval Date: 06-NOV-96
Trade Name: IOPAMIDOL
Dosage Form: INJECTABLE
Applicant: ELKINS SINN DIV AH ROBINS CO INC
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX

Original Abbreviated Application # 074593
Approval Date: 04-NOV-96
Trade Name: ETOMIDATE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): ETOMIDATE
OTC/RX Status: RX

Original Abbreviated and 505(b)(2) New Drug Approvals with Tentative Approval

Original Abbreviated Application #: 074578
Tentative Approval Date: 27-NOV-96
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: NOVOPHARM LTD
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application #: 074446
Tentative Approval Date: 26-NOV-96
Trade Name: TERAZOSIN HCL
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 040049
Tentative Approval Date: 26-NOV-96
Trade Name: NITRO NOVEN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVEN PHARMACEUTICALS INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Original Abbreviated Application #: 040048
Tentative Approval Date: 26-NOV-96
Trade Name: NITRO NOVEN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVEN PHARMACEUTICALS INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Original Abbreviated Application #: 040047
Tentative Approval Date: 26-NOV-96
Trade Name: NITRO NOVEN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVEN PHARMACEUTICALS INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020251 Labeling Supplement #: 005 To Original New Drug Application
Approval Date: 27-NOV-96
Trade Name: ZANTAC 150
Dosage Form: TABLET, EFFERVESCENT; GRANULE, EFFERVESCENT
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020095 Labeling Supplement #: 006 To Original New Drug Application
Approval Date: 27-NOV-96
Trade Name: ZANTAC 150; ZANTAC 300
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019675 Labeling Supplement #: 019 To Original New Drug Application
Approval Date: 27-NOV-96
Trade Name: ZANTAC
Dosage Form: SYRUP
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018703 Labeling Supplement #: 055 To Original New Drug Application
Approval Date: 27-NOV-96
Trade Name: ZANTAC 150; ZANTAC 300
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019389
Supplement #: 016
Approval Date : 26-NOV-96
Drug Name: BECONASE AQ NASAL SPRAY
Applicant: GLAXO WELLCOME INC

Application #: 018686

LabelingSupplement#:021 To Original New Drug Application
Approval Date: 25-NOV-96
Trade Name: NORMODYNE
Dosage Form: INJECTABLE
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019537LabelingSupplement#:028 To Original New Drug Application
Approval Date: 22-NOV-96
Trade Name: CIPRO
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #:050479Labeling Supplement#:012 To Original New Drug Application
Approval Date: 21-NOV-96
Trade Name: CORTISPORIN
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): POLYMYXIN B SULFATE; NEOMYCIN SULFATE; HYDROCORTISONE
OTC/RX Status: RX

Application #: 050205 Labeling Supplement #: 025 To Original New Drug Application
Approval Date: 21-NOV-96
Trade Name: CHLOROMYCETIN
Dosage Form: SOLUTION/DROPS
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): CHLORAMPHENICOL
OTC/RX Status: RX

Application #: 020560LabelingSupplement#:005 To Original New Drug Application
Approval Date: 21-NOV-96
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX

Application #:020233Labeling Supplement#:004 To Original New Drug Application
Approval Date: 15-NOV-96
Trade Name: RHINOCORT
Dosage Form: AEROSOL, METERED
Applicant: ASTRA USA INC
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX

Application #: 017970 Labeling Supplement #: 035 To Original New Drug Application
Approval Date: 15-NOV-96
Trade Name: NOLVADEX
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX

Application #:020638Labeling Supplement#:002 To Original New Drug Application
Approval Date: 14-NOV-96
Trade Name: VISTIDE
Dosage Form: INJECTABLE
Applicant: GILEAD SCIENCES INC
Active Ingredient(s): CIDOFOVIR
OTC/RX Status: RX

Application #: 020243 Labeling Supplement #: 009 To Original New Drug Application
Approval Date: 13-NOV-96
Trade Name: LUVOX
Dosage Form: TABLET
Applicant: SOLVAY PHARMACEUTICALS
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX

Application #: 009218 Labeling Supplement #: 083 To Original New Drug Application
Approval Date: 13-NOV-96
Trade Name: COUMADIN
Dosage Form: INJECTABLE
Applicant: DUPONT MERCK
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX

Application #: 020075 Labeling Supplement #: 005 To Original New Drug Application
Approval Date: 07-NOV-96
Trade Name: LIORESAL
Dosage Form: INJECTABLE
Applicant: MEDTRONIC
Active Ingredient(s): BACLOFEN
OTC/RX Status: RX

Application #: 019640 Labeling Supplement #: 015 To Original New Drug Application
Approval Date: 07-NOV-96
Trade Name: HUMATROPE
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX

Application #: 009838 Labeling Supplement #: 033 To Original New Drug Application
Approval Date: 06-NOV-96
Trade Name: RESERPINE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): RESERPINE
OTC/RX Status: RX

Application #: 020344 Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 04-NOV-96
Trade Name: REDUX
Dosage Form: TABLET
Applicant: INTERNEURON PHARMACEUTICALS
Active Ingredient(s): DEXFENFLURAMINE HYDROCHLORIDE
OTC/RX Status: RX